A Clinical Trial Agreement (CTA), Clinical Study Agreement or Clinical Research Agreement are all names for an agreement or contract between the university and another party relating to the conduct of a clinical trial or study.
In the case of an industry sponsored clinical study, such an agreement may be with the sponsor or a clinical research organization which is managing the study for the sponsor. A CTA defines the scope of work and formalizes the understandings between the parties for the conduct of the study. It contains legal and financial terms related to the university's conduct of the study.
The university’s research office has partnered with more than twenty industry sponsors to create Master Clinical Trial Agreements. These agreements define basic legal terms for studies while requiring study-specific information — including the financial terms and budget details — be included only in an appendix.
Conor Flynn, JD
A CTA is required when we are conducting a clinical study with another party, including industry, an academic partner or a clinical research organization. We use the CTA to define study-specific details, such as the number of subjects to be enrolled, ownership of the study data and/or samples, any intellectual property rights, publication rights and other matters pertaining to the study. If there is funding involved, the agreement clearly defines how much will be paid and when.
In the case of industry sponsored studies (such as regulatory studies for investigational new drugs or devices, post-market, observational or certain registry studies), the sponsor or its clinical research organization will provide an initial draft of the CTA.
For industry sponsored clinical studies, generally the sponsor initiates the CTA. If you receive such a document, it should be uploaded into Central Study Registration, along with the protocol and consent form. These documents will automatically be uploaded in the Click system. The CTA will then be assiged to a Clinical Contracts Administrator. They can answer any questions you may have about a CTA for clinical studies.
For industry sponsored clinical studies, any CTA you receive should be uploaded into Central Study Registration, along with the protocol and consent form. The CTA will be uploaded from Central Study Registration to Click under the 'Agreements' tab. The contract administrators and the sponsor are the primary negotiators however we inform the investigator and staff during the process and involve them as needed.
The clinical contract administrator sends the final document to the investigator for review and, if approved, signature. The administrator then gets the appropriate institutional signature(s) and, once fully executed, will return a copy to the investigator for his/her files.
There are several people with signature authority for documents and agreements related to clinical research and consequently the authority to bind UB and our investigators to the terms and conditions contained in such agreements. Investigators, staff and departments are not authorized to sign agreements on behalf of UB, our affiliates, the State University of New York or as individuals.
For industry sponsored clinical studies, the clinical contract administrator will review a CTA within two weeks and, following receipt of any responses to queries from the investigator/staff, return the revised draft to the sponsor.
The budget negotiations are handled separately, though both the budget and contract negotiations must be complete before a CTA can be signed. Negotiations can varies and depend on several factors, including the type and complexity of the study, whether there is a Master CTA in place, involvement of our affiliates, the responsiveness of the sponsor and the investigator or staff.